B-cell LymphomaPERSISTNCT07474051
Long-Term Follow-Up of AvenCell Sponsored CAR-T Cell Clinical Trials
An observational study of B-cell Lymphoma and Chronic Lymphocytic Leukemia, run by AvenCell Therapeutics, Inc. at 5 sites in Germany.
Trial summary
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy
- What is being tested?
- UniCAR02-T (IMP) With Targeting Module TM123, UniCAR02-T-pPSMA and Allo-RevCAR01- T with Targeting Module R-TM123
- How many people
- 178 participants
- Where
- 5 sitesGermany
- Study dates
- 29 Jan 2026to 30 Jan 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants Who Received an AvenCell CAR-T Cell Therapy
Who may be able to join
- Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.
- Participant signed written informed consent for the AVC-PERSIST study.
Who cannot join
- Participant is unable to provide written informed consent.
- Participant is unable to comply with study requirements in the eyes of the Investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites
Charité Universitätsmedizin Berlin
Berlin
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
Dresden
Universitätsklinikum Marburg
Marburg
Klinikum der Universität (LMU) Muenchen
Munich
Universitatsklinikum Ulm
Ulm
About this study
Official title: Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms.
Read the detailed description
To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.
- Conditions
- B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy, AML (Acute Myelogenous Leukemia), Prostate Cancer
- Being tested
- UniCAR02-T (IMP) With Targeting Module TM123, UniCAR02-T-pPSMA, Allo-RevCAR01- T with Targeting Module R-TM123, Allo-QuadCAR01-T
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniCAR02-T (IMP) With Targeting Module TM123Biological
No investigational product will be administered
UniCAR02-T-pPSMABiological
No investigational product will be administered
Allo-RevCAR01- T with Targeting Module R-TM123Biological
No investigational product will be administered
Allo-QuadCAR01-TBiological
No investigational product will be administered
| Study group | Role | What they receive |
|---|---|---|
| UniCAR02-T With Targeting Module TM123 (UC02-123-01) | All participants who previously received UniCAR02-T With Targeting Module TM123 in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: UniCAR02-T (IMP) With Targeting Module TM123 | |
| UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01) | All participants who previously received UniCAR02-T With Targeting Module TMpPSMA in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: UniCAR02-T-pPSMA | |
| Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01) | All participants who previously received Allo-RevCAR01- T Targeting Module R-TM123 in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: Allo-RevCAR01- T with Targeting Module R-TM123 | |
| Allo-QuadCAR01-T (AVC-203-01) | All participants who previously received Allo-QuadCAR01-T in the parent study will be enrolled in this cohort for long-term follow-up. Receives: Biological: Allo-QuadCAR01-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy
- Number of participants with serious adverse events (SAEs)
- Number of participants with new malignancies or recurrence of pre-existing malignancy
- Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder
- Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder
- Number of participants with new incidence of serious hematologic disorder
- Number of participants with new incidence of and/or recurring severe infection(s)
- Number of pregnancy complications and newborn health complications
Measured: Up to 15 years
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.
Measured: Up to 15 years
Progression-Free Survival (PFS)
PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
Measured: Up to 15 years
Event-free survival (EFS)
EFS is defined as the time from treatment initiation to the first occurrence of disease progression, relapse, initiation of new anti-cancer therapy, or death from any cause.
Measured: Up to 15 years
Cause of death
Cause of Death is defined as the underlying disease, treatment-related toxicity, or other medical event leading directly to a participant's death, as determined by the investigator.
Measured: Up to 15 years
RCR in peripheral blood
Number of participants with measurable RCR in peripheral blood
Measured: 15 years post last treatment
Pre-existing GvHD
Number of participants with new incidence or exacerbation of a pre-existing GvHD
Measured: 15 years post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start29 Jan 2026
- Primary completion30 Nov 2040 (estimated)
- Study completion30 Jan 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AvenCell Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AvenCell Europe GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474051
- Sponsor's protocol ID
- AVC-PERSIST
- Other IDs
- 2025-521717-67-00, 2025
- Acronym
- PERSIST
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy
- ClinicalTrials.gov ID
- NCT07474051
- Acronym / sponsor ID
- PERSIST / AVC-PERSIST
- Conditions
- B-cell Lymphoma, Chronic Lymphocytic Leukemia, Hematologic Malignancy, AML (Acute Myelogenous Leukemia), Prostate Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- AvenCell Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AvenCell Europe GmbH
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Nov 2040 (estimated)
- Study completion
- 30 Jan 2041 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms.
Detailed description
To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UniCAR02-T With Targeting Module TM123 (UC02-123-01) | – | Biological: UniCAR02-T (IMP) With Targeting Module TM123All participants who previously received UniCAR02-T With Targeting Module TM123 in the parent study will be enrolled in this cohort for long-term follow-up. |
| UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01) | – | Biological: UniCAR02-T-pPSMAAll participants who previously received UniCAR02-T With Targeting Module TMpPSMA in the parent study will be enrolled in this cohort for long-term follow-up. |
| Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01) | – | Biological: Allo-RevCAR01- T with Targeting Module R-TM123All participants who previously received Allo-RevCAR01- T Targeting Module R-TM123 in the parent study will be enrolled in this cohort for long-term follow-up. |
| Allo-QuadCAR01-T (AVC-203-01) | – | Biological: Allo-QuadCAR01-TAll participants who previously received Allo-QuadCAR01-T in the parent study will be enrolled in this cohort for long-term follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants Who Received an AvenCell CAR-T Cell Therapy
Key inclusion criteria (2 listed)
- Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.
- Participant signed written informed consent for the AVC-PERSIST study.
Key exclusion criteria (2 listed)
- Participant is unable to provide written informed consent.
- Participant is unable to comply with study requirements in the eyes of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UniCAR02-T (IMP) With Targeting Module TM123No investigational product will be administered | Biological | UniCAR02-T With Targeting Module TM123 (UC02-123-01) |
| UniCAR02-T-pPSMANo investigational product will be administered | Biological | UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01) |
| Allo-RevCAR01- T with Targeting Module R-TM123No investigational product will be administered | Biological | Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01) |
| Allo-QuadCAR01-TNo investigational product will be administered | Biological | Allo-QuadCAR01-T (AVC-203-01) |
Primary outcome
To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy
Time frame: Up to 15 years
* Number of participants with serious adverse events (SAEs) * Number of participants with new malignancies or recurrence of pre-existing malignancy * Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder * Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder * Number of participants with new incidence of serious hematologic disorder * Number of participants with new incidence of and/or recurring severe infection(s) * Number of pregnancy complications and newborn health complications
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to 15 years
Progression-Free Survival (PFS)
Time frame: Up to 15 years
Event-free survival (EFS)
Time frame: Up to 15 years
Cause of death
Time frame: Up to 15 years
RCR in peripheral blood
Time frame: 15 years post last treatment
Pre-existing GvHD
Time frame: 15 years post last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for B-cell Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Lymphoma and Chronic Lymphocytic Leukemia, run by AvenCell Therapeutics, Inc. at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy (time frame: Up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.